| Objective:To explored the safety and efficacy of Left atrial appendage device closure(LAAC)using Umbrella disc occluder(LAmbreTM)device in Non-valvular Atrial Fibrillation(NVAF)patients with or without prior catheter ablation(CA).Methods:From January 28,2019 to December 27,2019,a simple left atrial appendage closure or catheter ablation combined with left atrial appendage closure(one-step group)was performed in our center(Department of Cardiology,First Affiliated Hospital of Kunming Medical University)for non-valvular atrial fibrillation patients.Seven patients were treated with single left atrial appendage closure,Fourteen patients were treated with Catheter ablation(including radiofrequency ablation and cryoballon ablation)combined with left atrial appendage closure.The operation strategies of one-step group choose to ablate-first,Retrospective cohort study was used.simple left atrial appendage closure defined as simple occlusion group,catheter ablation combined with left atrial appendage closure defined as one-step group,and general data of sex,age,type of atrial fibrillation and course of disease were collected.In accordance with the guidelines and relevant research recommendations,the two groups developed postoperative antithrombotic treatment and follow-up program.clinical safety of this study was determined based on the occurrence of surgical-related severe pericardial effusion,pericardial tamponade,stroke/transient cerebral ischemia(transient ischemic attack,TIA),air embolism,occluder shedding,device-related thrombus,severe bleeding events(intracranial or gastrointestinal bleeding,etc.),vascular injury(hemorrhage,hematoma,pseudoaneurysm,etc.),surgical-related death,and other clinical serious complications.the validity is determined by the occurrence of successful occlusion(no residual flow or residual flow<3 mm),stroke/TIA and systemic thromboembolism events,occluder displacement and occluder-related thrombosis,death,etc.during follow-up.To evaluate the safety and efficacy of using LAmbreTM occluder for single LAAC or CA combined LAAC(one-step)therapy in patients with perioperative complications,successful occlusion during follow-up,thrombotic events,and device-related thrombosis.Results:1.baseline characteristicsA total of 21 patients with NVAF were enrolled in this study,including 7 cases with simple LAAC and 14 cases with CA combined with LAAC.The rate of one-step group had a history of stroke/TIA/thromboembolism more than the simple blocking group[10 cases(71.4%)and 1 case(14.3%),P=0.013],the difference was statistically significant;the average age of the simple blocking group and the one-step group were 73.00 ± 9.23 years old,63.36 ± 11.69 years old(P=0.073),CHA2DS2-VASc scores were 4.57±1.27,4.29± 1.94(P=0.729),HAS-BLED scores were 3.00(2.00-3.00),3.00(2.75-4.00)(P=0.466);the remaining two groups of patients There were no statistically significant differences in clinical characteristics such as the type of atrial fibrillation,the course of atrial fibrillation,the history of coronary heart disease,the history of diabetes,the history of hypertension,and the history of bleeding.2.procedure characteristicsAll patients completed the operation successfully(100%),LAAC was implanted with LAmbreTM occluder,16 patients were implanted with conventional occluder(occlusion disc diameter is 4-6mm larger than the fixed umbrella),5 patients were implanted A special model occluder is inserted,namely a small umbrella large plate(the diameter of the sealing plate is 12-14mm larger than that of the fixed umbrella).Five patients used a large model occluder(the size of the sealing plate?35mm).21 patients with left atrial appendage morphology:cauliflower type accounted for 66.7%,chicken wings type accounted for 14.3%,cactus type accounted for 4.8%,wind direction type accounted for 4.8%,other forms accounted for 9.5%.The average operation time of the one-step group was higher than that of the simple blocking group(190.43 ± 45.74min and 77.14± 17.76min,P?0.001).X ray time were 9.34min and 22.79± 5.23min,P=0.001).The difference is statistically significantOf all patients with LAAC,17 patients were successfully implanted at one time,and 4 patients(1 in the simple occlusion group and 3 in the one-step group,P=0.693)had undergone semi-recovery or The occluder was successfully implanted after full recovery,and the difference was not statistically significant;no patient changed to an occluder type or model because the occluder was not suitable.After operation,all patients achieved effective closure,and 3 patients(1 in the simple closure group and 2 in the one-step group,P=1.000)had a small amount of residual shunt(residual shunt ?3 mm)after Transesophageal echocardiography(TEE)evaluation,the difference No statistical significance;other patients achieved complete closure,that is,there was no residual shunt around the occluder.Postoperative hospital stays in the simple blocking group and the one-step group were 4.00(3.00-5.00)days and 5.50(3.00-6.00)days(P=0.283),respectively,and the difference was not statistically significant.3.Perioperative complicationsDuring the perioperative period,there were 3 patients with mild vascular injury.None of them required further intervention or extended hospital stay.Among them,1 patient(14.3%)in the simple occlusion group had bleeding at the puncture site and hemostasis after compression bandage;1 patient(14.3%)in the one-step group had 1 bleeding at the puncture site.After compression bandage,hemostasis occurred,and 1 case of inguinal hematoma occurred.P=1.000,the difference was not statistically significant.In the remaining two groups,no pericardial effusion,pericardial tamponade,stroke,air embolism,occluder detachment,device surface thrombosis,severe bleeding,surgery-related death and other serious adverse events occurred during the perioperative period.4.Changes in cardiac structure and function before and after surgeryTwenty-one patients underwent preoperative cardiac ultrasound examination,and 12 patients completed preoperative cardiac ultrasound examination.The results showed that there were no significant changes in the left atrium inner diameter,right atrium transverse diameter,right atrium long diameter,left ventricular end diastolic diameter,and left ventricular ejection fraction(EF value)before and after surgery(P?0.05),and the operation on the mitral valve,tricuspid valve,aortic valve,and pulmonary valve did not cause significant effects(P?0.05).5.Postoperative anticoagulation regimenAccording to the guidelines and relevant research recommendations after operation,combined with the clinical characteristics and individual choices of patients,anticoagulant therapy was formulated within 3 months after surgery.There were 0 patients and 1 patient taking warfarin in the simple block group and one-step group(P=0.469),4 patients and 6 patients taking dabigatran in the simple blocking group and one-step group,respectively(P=0.537).The patients in the simple blocking group and the one-step group taking rivaroxaban There were 3 patients and 7 patients(P=0.757),and the differences were not statistically significant.6.Follow-up results(1)Time of anticoagulant discontinuation after operation:21 patients discontinued oral anticoagulant after 3 months of operation(7 cases in the simple block group and 14 cases in the one-step group,P=1.000);(2)Residual shunt:21 patients achieved effective closure after 3 months of operation(ie TEE showed no residual shunt or residual shunt?3mm).(3)Stroke/TIA and systemic thromboembolic events:21 patients had no stroke/TIA and systemic thromboembolic events during 3 months to 1 year of follow-up.(4)Device-related thrombosis or occluder displacement:21 patients had no device-related thrombosis or occluder displacement during the follow-up period from 3 months to 1 year after surgery.(5)Pericardial effusion:21 patients had no pericardial effusion during 3 months to 1 year of follow-up.(6)Death:There were no deaths in 21 patients during the follow-up period from3 months to 1 year.7.Surgical cost statisticsBased on the comparison between the average cost of surgery in 21 patients in our hospital and the use of new anticoagulants in patients who did not undergo surgery,the economic benefit of LAAC or one-step surgery was evaluated.In our hospital,the average operation cost of pure left atrial appendage occlusion is 71209.8?,and the average cost of one-step payment is 136760.7?.Calculated based on the maximum 50%of the medical insurance deductible rate,the average surgical cost for simple left atrial appendage closure is 35604.9?,and the one-step average cost is 68380.35?.According to the unit price and dosage form of our hospital,dabigatran 171.84?/box(10tablets),17.18?/tablet,rivaroxaban:138?/box(5tablets),27.6?/tablet,all new anticoagulant drugs It is a self-financed drug.Aspirin is calculated according to the unit price and dosage form of our hospital,aspirin:15.50?/box(30tablets),0.52?/tablet.According to the postoperative anticoagulation protocol of this study,patients took LAAC or one-step anticoagulants for 3 months,and then took aspirin for life:(1)The cost of treatment for patients at full self-funded LAAC surgery will be lower than that of patients taking new anticoagulants without surgery after about 5 years;(2)The treatment cost of patients with one-step surgery at their own expense will be lower than that of patients taking new anticoagulants without surgery after about 10 years;(3)The treatment cost of patients who using Medicare with LAAC surgery after 5 years is significantly lower than that of patients taking new anticoagulants without surgery;(4)The cost of treatment for one-step medical insurance patients is about the same as that of patients taking new anticoagulants without surgery after about 5 years.In general,the economic benefit of LAAC or one-step surgery is better than taking new anticoagulants.Conclusion1.The use of LAmbreTM occluder for left atrial appendage occlusion or one-step surgery has a good success rate and near-to-medium-term efficacy.It is a feasible plan for preventing stroke in NVAF patients.In order to better determine its safety and effectiveness,it is necessary to Conduct more randomized controlled trials;2.The optimization of the structural design of the LAmbreTM occluder can help patients with complex anatomical left atrial appendages,but its scope of application needs to be further confirmed;3.Based on current drug prices and surgical costs,the economic benefit of left atrial appendage occlusion or one-stop surgery after 5 years is better than taking new oral anticoagulants. |
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